In This Article:
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OCREVUS (ocrelizumab) data to show sustained reduction in disability progression through 8 years for primary progressive multiple sclerosis (PPMS) and 7.5 years for relapsing MS (RMS)
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Long-term safety analysis of all clinical trials will reinforce the consistently favourable benefit-risk profile of OCREVUS
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ENSPRYNG (satralizumab) data to show efficacy and safety sustained over four years of treatment for people living with neuromyelitis optica spectrum disorder (NMOSD)
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Study design for SAkuraBONSAI, a new study on disease activity and progression in ENSPRYNG patients, who are treatment naïve or where prior rituximab (or biosimilar) treatment has failed, will be presented
Basel, 5 October 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new OCREVUS® (ocrelizumab) and ENSPRYNG® (satralizumab) data will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from 13 - 15 October 2021. These data include 38 abstracts highlighting new longer-term efficacy and safety for both OCREVUS and ENSPRYNG, as well as our ongoing efforts to evaluate the impact of the COVID-19 pandemic for people living with MS. Additional data will show how a deeper scientific understanding of MS and NMOSD in diverse patient populations could help ensure access to treatment.
“The longer-term efficacy and safety data for both OCREVUS and ENSPRYNG reinforce the impact of these treatments - by significantly slowing disease progression in MS and by preventing debilitating relapses in NMOSD, respectively,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We continue to see that early and ongoing treatment markedly improves outcomes, and we’ll continue to use scientific and real-world insights to improve our understanding and ways to support people living with these neurological disorders.”
Multiple sclerosis (MS)
Roche will present 27 MS studies, including long-term data that show earlier treatment with OCREVUS continues to impact disability progression up to 8 years in people with primary progressive multiple sclerosis (PPMS) and up to 7.5 years in people with relapsing multiple sclerosis (RMS) in the Phase III open label extension studies. Additionally, updated long-term safety analysis of all clinical trials in patients with RMS and PPMS will reinforce the consistently favourable benefit-risk profile of OCREVUS.
Roche remains committed to addressing health disparities and we believe inclusive research can improve outcomes and derive insights that may address treatment barriers. A subgroup analysis of three studies (SaROD, CHORDS ENSEMBLE PLUS) in Black, African-American, Hispanic and Latino populations treated with a 2-hour OCREVUS infusion will be presented.
Neuromyelitis optica spectrum disorder (NMOSD)
New longer-term results from the SAkuraStar and SAkuraSky OLE studies for ENSPRYNG will show efficacy observed in the pivotal trials is sustained with high proportions of patients remaining free from relapse over four years of treatment. Similarly, safety data from the SAkuraStar and SAkuraSky OLE studies will show the favourable safety profile of ENSPRYNG is sustained with longer-term treatment. ENSPRYNG has been approved in 58 countries globally, including in the U.S. as the first and only subcutaneous treatment for adults with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD. ENSPRYNG has also been approved for both adults and adolescents in the European Union, Japan, Canada and Switzerland.
Roche is dedicated to increasing scientific understanding of NMOSD and improving care for all people living with the condition. The study design will be presented for SAkuraBONSAI, a prospective, open-label study of ENSPRYNG to generate data to further the understanding of the disease activity and mechanism of action of ENSPRYNG in patients living with AQP4-IgG seropositive NMOSD who are treatment naïve or where prior rituximab (or biosimilar) treatment has failed. Other presentations will examine the development of new tools and techniques to identify patients with NMOSD and assess disability better.
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